Wednesday, 31 December 2014

I just went to the UPS Store to print out an essay. When I checked Google Drive the final version was not there even though I uploaded it 6 hours ago, so I had to use last night's version. I had a very slim chance of winning with the final version but I am not holding my breath over last night's version. I will stick to sending messages to myself by email from now on.

On behalf of the scientific and organizing committees of The 15th International
Congress of the International Society for Ethnopharmacology
which will be held on 5-8, May, 2015 in Petra, Jordan. It is our
pleasure to invite you to participate in this congress organized by
Al-Balqa Applied University in collaboration with the International Society for Ethnopharmacology.
The topics of the congress include different fields of research related
to ethnopharmacology which aim to bring together researchers from all
over the world with their recent achievements in ethnopharmacology and
medicinal plant science, innovations and industry.

Traditional phytoremedies for the treatment of menstrual disorders in district Udhampur, J&K, India

Abstract

Ethnopharmacological relevance

Herbal
remedies form an integral part of healing and are considered to be the
oldest forms of health care known to mankind. The present study aims to
document traditional phytoremedies for the treatment of menstrual
disorders in Udhampur district of J&K, India.

Material and methods

The
informants were interviewed directly and information was gathered about
plants used in different menstrual disorders. The data was further
analyzed for use-value (UV), factor informant consensus (Fic) and fidelity level (Fl).

Results

In all, 62 informants were interviewed. Most of the informants (66%) were females. The patients prefer female healers over male vaids and hakims.
A total of 50 plants were used to cure different menstrual disorders.
Seeds were found to be of utmost medicinal importance (43.8%) followed
by leaves (20.8%) and fruits (16.7%). Oral administration was observed
to be the main mode (90.0%) of intake of medicine. The plants with high
use-value were Triticum aestivum (UV=1.76), Taraxacum officinale (UV=1.16), Citrus limon (UV=0.95), Allium cepa (UV=0.79), Cicer arietinum (UV=0.77), Trigonella foenum-graecum (UV=0.66), Rubia manjith (UV=0.56), Ocimum tenuiflorum (UV=0.56) and Oryza sativa (UV=0.52). The various menstrual disorders were classified into 7 categories. The values of Fic
varied between 0.96 (dysmenorrhea, itching and foul smell) and 0.92
(menorrhagia). The 100% Fl value was scored by 20 plants. Leucorrhea
reported the highest 5 plants with 100% Fl. Nearly 40% of the
formulations had two or more plants.

Conclusion

Plants
used for the treatment of different menstrual disorders were documented
and analyzed for ethnogynecological problems. The study revealed some
plants like Triticum aestivum, Rubia manjith, Dalbergia sissoo, Raphanus sativus, Citrus limon, Allium cepa, Trigonella foenum-graecum, Elettaria cardamomum etc. to be of great importance vis a vis
menstrual disorders. Further pharmacological studies of these plants
may provide some important drugs for the treatment of common menstrual
disorders.

Consequences of a competitive research culture

What
is high quality science? Rigorous, accurate, original, honest, and
transparent were the words selected by scientists who took part in the
UK Nuffield Council on Bioethics' project
to assess the ethical consequences of the culture of research. The
project surveyed 970 scientists and held several discussion events in
the UK as well as meetings with funding bodies, publishers, editors.

Scientists
reported that they were motivated to do research to make discoveries
that benefit society and to improve their own knowledge and
understanding. However, they raised concerns that their working
environment did not support their goals and visions. Worryingly, for
some, the culture of research in the UK was such that it even encouraged
poor quality research practices, such as rushing to finish and publish
research and employing less rigorous research methods. High levels of
competition for funding and jobs and promotions were noted as driving
factors for these behaviours.

The Research Excellence
Framework (REF) results (to be released on Dec 18), which inform
allocation of core funding to higher education institutes, were a key
issue for those surveyed. Despite a change in format since the last such
exercise (eg, REF assessment panels were instructed not to make any use
of journal impact factors in assessing the quality of research
outputs), REF still causes researchers much anxiety, and misperceptions
and mistrust about the system exist. Scientists still think that
publishing in high-impact journals is the most important element in
determining funding, jobs, and promotions, along with article metrics
such as citation numbers.

The Lancet Series on Research: increasing value, reducing waste
also noted problems with reward systems—they incentivised quantity more
than quality and novelty more than reliability. “Research rewards and
integrity: improving systems to promote responsible research” is the
theme of the 4th World Conference on Research Integrity
(May 31–June 3) in Rio de Janeiro, Brazil, 2015. Critical examination
of rewards systems is warranted by all those involved in the research
enterprise since existing approaches are putting immense pressure on
scientists and could be damaging the very practice of science itself.

Prunus africana (Hook.f.) Kalkman: The Overexploitation of a Medicinal Plant Species and Its Legal Context

Abstract

The
linkage between herbal medicines and the sustainability of medical
plants from which they are manufactured is increasingly being understood
and receiving attention through international accords and trade
labeling systems. However, little attention is paid to the fair trade
aspects of this sector, including the issue of benefit-sharing
agreements with traditional societies whose knowledge and resources are
being exploited for commercial herbal medicine development and
production.

This article examines the case of Prunus africana (Hook.f.) Kalkman, from equatorial Africa. While the conservation and cultivation dimension of the trade in P. africana
has been much discussed in literature, no research appears to have
focused on the traditional resource rights and related ethical
dimensions of this trade in traditional medicine of Africa. Serving as a
cautionary tale for the unbridled exploitation of medicinal plants, the
history of P. africana extraction is considered here in the
context of relevant treaties and agreements existing today. These
include the Nagoya Protocol, a supplementary agreement to the Convention
on Biological Diversity, the Trade-Related Aspects of Intellectual
Property Rights agreement from the World Trade Organization, and two
African regional frameworks: the Swakopmund Protocol and the
Organisation Africaine de la Propriété Intellectuelle Initiative.

In
the context of strengthening medicinal plant research in Africa, a
novel international capacity-building project on traditional medicines
for better public health in Africa will be discussed, illustrating how
access and benefit sharing principles might be incorporated in future
projects on traditional medicines.

Introduction

International interest in supporting
and promoting the use of traditional, complementary and alternative
medicine continually expands, adversely affecting biological resources.1
The use of biological elements, including flora, fauna, and fungi, for
local medicine has been well recorded and documented around the world.2,3
The current value of traditional medicine and its associated trade is
larger than it has ever been because of population growth, urbanization,
and rural unemployment.3
Commercial demand for traditional and alternative medicine has been
linked to increasing urbanization, rural poverty, and lack of access to
health care services in developing countries.3,4
Simultaneously, a growing international market for standardized herbal
products is adding to pressure on selected high-demand species.

While
the linkages between herbal medicines and the sustainability of medical
plants from which they are manufactured is being understood and
receiving attention through international accords and trade labeling
systems, little attention is paid to the fair trade aspects of this
sector, including the issue of benefit sharing agreements with
traditional societies whose knowledge and resources are being exploited
for commercial herbal medicine development and production.5–10
In this article, the term “sustainable” is used according to the
definition of the Convention of Biological Diversity (1992), Article 2,
which defines the term as “the use of components of biological diversity
in a way and at a rate that does not lead to the long-term decline of
biological diversity, thereby maintaining the potential to meet the
needs and aspirations of present and future generations”.11
The commercialization of medicinal plants needs to account for the
limits of the resource to ensure the sustainable, that is to say the
long-term and continued, harvesting of species.

To face
the challenges associated with sustainable harvesting of medicinal
species and the protection of human health, national and international
policies have been created relating to safe and appropriate development
of traditional medicine as well as preventing misuse of genetic
resources and associated traditional knowledge in international markets.
The African plant species Prunus africana (Hook.f.) Kalkman
makes for an interesting and important historical case study. This is
due to its popularity in the European pharmaceutical market, the lack of
access and benefit sharing arrangements that have characterized its
exploitation by European companies, and its susceptibility to
overharvesting as a habitat-specific, slowly maturing and destructively
harvested species.12,13

P. africana
is a secondary forest canopy tree species that has been declining over
much of its geographic range in sub-Saharan Africa. Farming,
slash-and-burn agriculture, and habitat loss have long been primary
causes of Afromontane deforestation, all of which threaten the survival
of P. africana.14 However, the fundamental threat to the species P. africana
has been large-scale unsustainable harvesting in Afromontane forests
for international trade, resulting in ecologic damage of the environment
in general.15,16 International attention on Prunus harvesting methods (Fig. 1) has been focused on Cameroon as nearly 70% of the world's supply comes mainly from the slopes of Mount Cameroon.14,17 The European pharmaceutical market has driven demand for the bark of P. africana, causing an equally devastating impact on Prunus stocks in other African countries.

The trade in P. africana
bark extract for the treatment of benign prostatic hyperplasia (BPH)
had led to a very lucrative international market worth approximately
US$220 million in the late 1990s.17
To satisfy this demand, over 3300 tons of bark were collected annually,
leading to concerns of the long-term sustainability of harvesting and
the conservation of the species.17 As a method of regulating trade and preventing destruction of wild populations, P. africana
was included in Appendix II of the Convention on International Trade in
Endangered Species (CITES) of Wild Flora and Fauna at the Ninth CITES
Conference of the Parties in 1995.

P. africana has been discussed extensively in literature with reference to its plant ecology and genetic diversity,18–22 traditional uses,14,23,24 chemical constituents in relation to treating BPH,25–28 exploitation and conservation strategies14,17,29–36 and policy and regulation aspects of trade.15,37
Despite the extensive literature, less attention was paid to the legal
aspects of trade, which started in a legal vacuum in the early 1970s,
until 1992, when the first international agreement on the conservation
of nature, the Convention on Biological Diversity (CBD), was signed. The
ongoing global harvest of medicinal species for national and
international markets was an important factor in developing legal
frameworks that address ownership of traditional knowledge and access
and benefit sharing principles.

Of importance to this article is how the overexploitation of P. africana
has occurred in the absence of legally binding treaties, the historic
neglect of customary ownership issues, the disregard for the rights of
traditional knowledge holders, and the complicity of governments in
allowing unsustainable trade, attributed by some commentators to endemic
corruption within the concerned governments.38,39

When commercial harvesting of Prunus
bark took place from the 1960s to the 1990s, no existing forestry laws,
permits, or harvesting controls made reference to intellectual property
rights, and over-exploitation occurred without just compensation for
communities' traditional knowledge. Although legal conservation
agreements are now established, no intellectual property rights
agreements pertaining to the use of P. africana for BPH have
been put in place. This stands as an important cautionary tale for the
importance of a comprehensive regulatory and ethical framework to be in
place for the exploitation of commercially viable species. Much has
changed at the legal level since the commercialization of P. africana
took place. To illustrate this, this article builds on a case study
developed as part of an international project, the Multidisciplinary
University Traditional Health Initiative (MUTHI), in which the current
regulatory framework and training in ethnopharmacologic research aspects
will be discussed as an example of strengthening plant research
capacity in Africa.40

Ecology and Distribution

P. africana (synonym Pygeum africanum [Hook.f.]) belongs to the Rosaceae family. P. africana is a widespread evergreen tree, growing at an altitude of 1500–2000m, usually 10–25m high with alternate leaves, a straight cylindrical trunk, a dense rounded crown, and small white or cream fragrant flowers. Prunus
provides habitat and food for endemic birds; rare primates; insects;
and nonvascular canopy epiphytes, such as orchids, ferns, and mosses.31 The single seed-bearing fruit is eaten and spread by local fauna over tropical and subtropical parts of Africa14,24,29,31,41 but is most abundant in Cameroon and Madagascar, where montane forests occupy large areas.42 Within the Prunus genus, P. africana and P. crassifolia (Hauman) Kalkm. are the only wild species occurring in Africa. Other known Prunus species are plums (P. domestica L.), cherries (P. avium L.), peaches (P. persica L.), almonds (P. dulcis [Mill.]), and apricots (P. armeniaca L.).14 All of them are commercially interesting species.

Traditional Uses

Many publications refer to the medicinal value of P. africana
to treat fevers, gonorrhea, stomach pain, chest pain, kidney disease,
urinary symptoms, and malaria, as well as for arrow poison and as a
purgative for cattle.23,42,43 Stewart24 illustrated many other ailments treated with Prunus in Uganda and described its anti-inflammatory and analgesic properties. P. africana is known by many different vernacular names throughout sub-Saharan Africa,24,44 which reveal interesting information on traditional uses. For example, in the Fulani language it is referred to as dalehi, meaning “plant that has many uses,” a correct assessment of P. africana, one of the most important tree species worldwide for subsistence and international trade.

Pharmacologic Research

In the mid-1960s, the bark of P. africana was discovered to have pharmacologic properties beneficial to the management of BPH and was patented for this purpose.45
BPH, a noncancerous enlargement of the prostate that causes discomfort
in older men, is present in more than 50% of men older than age 60
years; 15%–30% of these men report lower urinary tract symptoms.46
Symptoms of men with BPH include all or some of the following; weak
urinary stream, urinary hesitancy, nocturia, incontinence, and recurrent
urinary tract infections.47
Because of high costs and adverse effects resulting from surgery and
pharmacologic drugs, many patients use alternative phytotherapeutic
treatments based on P. africana extracts (e.g., tadenan, bidrolar, and Pygenil).17,48,49

The effectiveness and safety of the bark extract in BPH treatment have been confirmed in multicenter trials50 and clinical trials46,51,52,53 and has been discussed in many systematic reviews.28,54,55,56 However, many scientists argue that no conclusions can be made that P. africana extracts prevent long-term complications from BPH.48,57,58

So
far, few companies have taken up the challenge to conduct randomized,
double-blind, placebo-controlled studies because of high costs that are
difficult to recoup because natural products cannot be patented as
inventions.48
More research is needed, preferably on the African continent itself.
Despite the absence of hard scientific evidence on the long-term aspect
of phytotherapy in the treatment of BPH, P. africana and other therapeutic elements have been widely used since the 1970s, contributing to ongoing exploitation.

Exploitation

The discovery of the medicinal properties of Prunus
bark initiated a decades' long harvest for international market needs,
in which Cameroon supplied over half, followed by Madagascar, the
Democratic Republic of the Congo (DRC), Kenya, Uganda, and Equatorial
Guinea.17,30
In the early 1970s, Cameroon's traditional small-scale harvesting for
medicinal purposes shifted to large-scale exploitation when Plantecam
Medicam, a subsidiary of the French company Laboratoires Debat, obtained
a monopoly for commercial exploitation and trade in P. africana bark and bark extract until 1986.14,15,37 From 1976 until 1996, Plantecam received yearly permits to exploit over 500 tons.15,34 Initially, Plantecam Medicam, the company founded by J. Debat, who patented P. africana
for use in the treatment of BPH, established a harvesting system based
on only partial debarking the trees. This was to prevent full debarking,
which would lead to tree death. After 5 years, however, Cameroon's
forestry department ended the company's monopoly. Subsequently, 50 new
licenses were awarded to local organizations to harvest bark. The
previous tight control over harvesting practices was thus lost. Multiple
stakeholders harvested the bark and sold it to the companies concerned,
who continued to buy Prunus bark, despite the rapid spread of destructive harvesting practices.

By 1993, a UNESCO report noted that: “Despite assurances from the two major companies involved in the harvest and processing of Prunus africana
bark, considerable concern has been expressed by rural communities,
traditional healers and government departments in East and Central
Africa about the sustainability of this international trade.”14 Similar concern was also expressed by the Worldwide Fund for Nature and the International Council for Birdlife Preservation.

In 1994, there was an outbreak of illegal exploitation on Mount Cameroon, fueled by unauthorized buyers who had exhausted Prunus stocks in other parts of the country.17,59
Buyers encouraged villagers to harvest for them, offering greater
rewards than before, but substantially less than Plantecam offered legal
suppliers. By 1995, Prunus harvesting was destructive and
uncontrolled and had become a major source of cash income for local
young men and their households.17,59
Trees were felled or totally stripped by villagers to supply bark to
illegal buyers, negatively affecting the surrounding ecosystem. Fashing41
reported that 68% of the exploited trees were dead or experiencing
canopy dieback. The large-scale bark exploitation caused severe damage
to the P. africana population and led to concerns of the
long-term sustainability of harvesting and conservation of this species.
Since Plantecam's closure in 2000, companies such as AFRIMED, SGPA, and
CEXPRO have taken over the exploitation and trade in P. africana in Cameroon.44Approximately 20 different European companies are involved in the production and sale of herbal preparations containing P. africana.17 The most important European companies that have worked with P. africana
bark extracts for medicinal purposes are Laboratoires Debat (France)
and its subsidiary Plantecam Medicam, Madaus (Germany and Spain),
Prosynthese (France), and Inverni della Beffa and Indena Spa (Italy).
The latter imports bark extract from Madagascar while the other European
companies import processed or unprocessed bark from Cameroon, Kenya,
Uganda, and the DRC.14
Products are sold as tablets or capsules known by various names such as
Tadenan by Laboratoires Debat and Pygenil by Indena Spa; as herbal teas
to treat BPH; and as 1-day formulas containing a blend of vitamins,
minerals, nutrients, and herbs, such as P. africana. The
long-term sustainability of the species was of concern because of the
sheer quantity of bark that was harvested yearly to supply the European
market, valued at over 200,000,000 million in the late 1990s.17 Although the need for alternative sources of bark harvesting has been recommended,14,17 collection does still take place from wild populations of P. africana. Since the year 2000, bark from wild P. africana
has been exported for commercial purposes from Burundi, the DRC, Congo,
Cameroon, Equatorial Guinea, Kenya, Madagascar, Tanzania, Uganda, and
South Africa. In Cameroon, mean bark yield has been estimated at 55kg per tree with variations in yields of 38–73.8kg.14 From 1 ton dry weight (2 tons fresh weight of bark), 5kg of extract are produced.17 A search selection in the CITES trade database showed that a total of 7,604,040kg of P. africana
bark (gross output) has been harvested for commercial use in the period
2000–2011 from Cameroon, which had been collected from approximately
138,255 trees.60
Although this number does not offer a complete picture (because no data
are available for 2008 and 2010 for Cameroon), it provides a rough
indication of the amount of P. africana harvested in the last decade, affecting wild populations.

The destructive exploitation of P. africana until the late 1990s also had consequences for wildlife,41
forest habitat, and genetic resource conservation, as well as for local
communities that depend on this valuable and increasingly scarce
resource.14

The main reasons for P. africana
overharvesting are poverty, corruption, poor regulation from the EU
side, and lack of enforcement from the African side. Poverty and
corruption on the supply side are major factors leading to resource
depletion. By employing harvesters from areas (Western Province) other
than Mount Cameroon, Plantecam deprived local communities of income from
legal Prunus bark collection for commercial purposes leading
to illegal harvesting activities overnight, felling trees to maximize
harvest, stealing products from harvesters employed by Plantecam, and
selling products to middlemen who resold them to Plantecam at higher
prices.49 Kenyan conservationist and Nobel laureate Wangari Mathaai has commented on the subject of Prunus overharvesting:

It is those educated
foresters. It is the ministers in government. It is the government
personnel who are charged with the responsibility of protecting these
resources. So, if they become corrupt and allow themselves to be
persuaded by the agents, then of course, as a country, we are losing.
You are talking about a country where 56 percent of the people are poor.
If you show them a few thousand shillings and you tell them to go into
the forest and cut a muiri tree [Prunus africana], and the forester is
willing to share the loot, it is very, very difficult to convince such a
person that the tree is so valuable that one day, it could be turned
into an extremely valuable drug and therefore, he should not cut it. It
is very, very difficult. That is why we say poverty is both a cause and
reason for environmental destruction.39

On
the demand side, EU regulators lack control in requiring evidence by
European importers of traceability and sustainability in the use of
natural products from other countries. Eventually, this was addressed by
invoking a global regime—CITES—when it was clear that no European
oversight or control was in place.17
On the supply side, there was no enforcement of existing African Union
policy relating to the 1998 OAU Model Law on access and benefit sharing
principles when traditional knowledge and traditional resources are used
for medicinal development.61

Conservation Policy

Conservation studies and trade assessments conducted mainly during the 1990s11,14,17 led to many conservation measures. To protect the wild populations cultivation programs started (Fig. 2),
which included new enrichment plantings, plantations, and small-scale
farm production, the protection of genetic resources by in situ and ex situ conservation practices and formulating new regulations.23

As previously discussed, in 1995 Prunus
was listed as an endangered species in Appendix II of CITES. Appendix
II species are not directly threatened with extinction but may be if
trade is unregulated. Therefore, each member state of the Convention
must designate a Management Authority responsible for issuing permits
and compiling annual reports on their international trade in specimens
of CITES-listed species. Exporting countries have to issue permits, and
countries of import must check permits upon entry to regulate trade.17
The Food and Agriculture Organization panel of experts on forest gene
resources also recognized the importance of this species and listed P. africana as 1 of the 18 top-priority species for action in Africa.62 To the authors' knowledge, this listing has not been updated since then. As an extra measure of protection, P. africana was listed in the Tree Conservation Database of the World Conservation Monitoring Centre. The Prunus genus has also been identified as one of the priority genera for in situ and ex situ conservation by the International Board for Plant Genetic Resources.14 At the 12th CITES meeting in Leiden in 2002, P. africana
was selected for a Significant Trade Review to identify problems and
solutions in implementing the Convention. The Significant Trade Review
should ensure that species do not decline because of international trade
while they are listed in Appendix II. A negative review would result in
transferring the species to Appendix I and prohibit commercial trade.
At the 16th CITES meeting in Lima, Peru, in 2006, the Plants Committee
categorized P. africana from Burundi, Cameroon, the DRC,
Equatorial Guinea, Kenya, Madagascar, and the United Republic of
Tanzania as “of urgent concern.”63
The Plants Committee established a working group to guide the relevant
range states on implementation of recommendations for this species. The
Terms of Reference are described in the Plants Committee 16 summary
record.63

Even
with these various levels of legislative protection, conservation
efforts have varied across countries throughout Africa, as described in
Bodeker et al. and summarized in Box 1.64–68
The species has been subject to international and regional agreements
on traditional knowledge of plants and access and benefit sharing
principles, as discussed in the following section.64

Box 1. Conservation Policy of the 5 Most Important Prunus africana Export Countries in the Last 10 Years (CITES Trade Database)

Cameroon

There
have been extensive conservation efforts by a range of national and
international organizations and the planting of around 625 hectares with
1.5 million trees between 1976 and 2008 in western Cameroon.65 Plantecam's harvesting license included a provision that held them responsible for establishing 5 hectares of Prunus
plantations yearly, since the early 1990s, which the company failed to
do. Although this contractually mandated replanting was not carried out,
small-scale farmers took the initiative to cultivate the tree in hopes
of benefiting from its various uses. Small-scale agroforestry may well
be a more feasible plan for cultivating Prunus than large plantations in a region where land is scarce and politically disputed.38
In response to growing conflicts among villagers and outside
stakeholders, the Mount Cameroon Project (MCP) was created to facilitate
a process of conflict management with regard to the harvesting and
trading of P. africana.66
The MCP focuses on developing partnerships between local communities,
government, and business and aims to ensure improved, sustained benefits
to local communities accruing from exploitation.

Cameroon
was unable to fully meet the Lima requirements. In October 2007, the
European Commission Scientific Research Group gave negative advice on
the import of P. africana to European Union member states.34 This trade ban lasted until December 2010.

Democratic Republic of Congo

Because
of the political unrest present in this country, it has been difficult
to assess the state of the species. As of 1997, it was reported that
harvesting was occurring from the mountain range of the Kivu area and
exported through Kinshasa or Kenya.17
At its 45th meeting (Paris, France, June 19–22, 2001), the Standing
Committee accepted a report of the Secretariat (SC45 Doc. 11.2) in which
it described the continuing fraudulent use of export permits issued by
the Management Authority of the Democratic Republic of the Congo. The
Committee recommended that the Parties refuse any import of specimens of
CITES-listed species from and any export or re-export of such specimens
to the Democratic Republic of the Congo (CITES No. 2001/039). The
recommendation to suspend trade with the Democratic Republic of the
Congo was withdrawn in 2002 (CITES No. 2002/065). In 2004, The
Scientific Review Group (SRG) suspended trade with the Democratic
Republic of the Congo because of unsustainable harvesting, pending
review of management practices.34
Later the same year, after reviewing data from range states (Equatorial
Guinea, Tanzania, Cameroon, and Madagascar) the SRG lifted the ban on
imports from the DRC.

Kenya

As of 1995, P. africana
bark was harvested on privately owned forest land because exploitation
in protected areas had been forbidden through its addition to Appendix
II of CITES.17
The CITES management authority for Kenya objected to the continued
harvest without a Detriment Study and halted exploitation at the end of
2002.23 As in other countries, there is a movement to create cultivation based Prunus production.23

Equatorial Guinea

Sunderland and Tako29 report that the 1997 Appendix to the 1995 Forestry Law of Equatorial Guinea refers to the sustainable management of P. africana,
but a general lack of knowledge as to how to manage and exploit this
species inhibits the potential for sustainability. Findings of
Sunderland and Tako29
show unsustainable exploitation of this species on the island of Bioko.
In Notification to the Parties No. 2004/024 of April 2004, The
Secretariat advises all Parties to suspend trade with Equatorial Guinea,
which was withdrawn in June 2004 (No. 2004/047). Navarro-Cerrillo et
al. (2008) reported a strong negative effect of harvesting practices on P. africana population structure and mortality after harvesting severely depleted the species.67
Extraction in new areas and lack of recruitment and establishment of
new seedlings might lead to the commercial extinction of the species in
Bioko. As of Feb 3, 2009, Equatorial Guinea is subject to a
recommendation to suspend trade.67

Uganda

In
1992, bark was harvested on a trial basis from the Kalinzu-Maranaganbo
Forest and the Kasyoha-Kitomi Forest Reserve in western Uganda. Bark was
transported to Mombasa, Kenya, where it was exported to France.
However, the bark harvest was destructive and the sole exporter ceased
operations in Uganda.17
Prunus has been listed on Annex II of the European CITES endangered
list in 1995. Currently, there are calls within Uganda for sustainable
cultivation and harvesting by local cooperatives in forest sites within
so-called multiple-use ecosystems, including Bwindi Impenetrable
National Park, Mabira Forest, Kibale National Park, Kalinzu Forest
Reserve, Kashoha, and Mount Elgon National Park.68

There
are two international legal frameworks of importance to the
exploitation and development of traditional knowledge of medicinal
plants in Africa: (1) the Convention on Biological Diversity (1993),
with its subsidiary the Nagoya Protocol (2010) on access to genetic
resources and the fair and equitable sharing of benefits arising from
their use to the CBD, and (2) the 1995 Trade-Related Aspects of
Intellectual Property Rights (TRIPS) agreement. There are two regional
frameworks: the Agreement of February 24, 1999, revising the Bangui
Agreement of March 2, 1977, on the creation of an African Intellectual
Property Organization and the Swakopmund Protocol (2010).

The Convention on Biological Diversity

The
CBD entered into force in 1993 to promote the conservation of
biological diversity, the sustainable use of its components, and the
fair and equitable sharing of benefits arising from the use of genetic
resources. In 2010, the Nagoya Protocol was adopted to supplement the
intellectual property rights sections of the CBD. This protocol is the
latest attempt to develop an international instrument complementing
other previous developed access and benefit sharing instruments. The
protocol has yet to come into effect, but the principles have widely
been accepted and to date, 92 parties have signed and 51 have ratified
the protocol.69
The United Nations (UN) CBD secretariat revealed in its July 14 press
release that the Protocol will now enter into force on October 12, 2014,
following its ratification by 51 parties to the CBD. “The entry into
force of the Nagoya Protocol will provide greater legal certainty and
transparency for both providers and users of genetic resources, creating
a framework that promotes the use of genetic resources and associated
traditional knowledge while strengthening the opportunities for fair and
equitable sharing of benefits from their use. Hence, the Protocol will
create new incentives to conserve biodiversity, sustainable use its
components, and further enhance the contribution of biodiversity to
sustainable development and human well-being.”70

The TRIPS agreement

The
TRIPS agreement came into force in 1995 and introduced minimum global
standards for protecting and enforcing nearly all forms of intellectual
property rights, including those for patents, but makes no reference to
traditional knowledge. Contrary to the CBD position that customary
ownership constitutes a form of intellectual property protection, TRIPS
proposes that without patent protection, ownership does not exist. The
TRIPS agreement requires countries to generate their own patent and
intellectual property systems, known as sui generis systems,
which are unenforceable outside their own patent domain; despite efforts
to reconcile the CBD and TRIPS through the Doha round of trade talks,
no definitive progress was made.71 As of July 2012, there was no agreement on how best to frame sui generis systems, especially with respect to the following issues:72

•Definition of traditional knowledge;

•Owners and beneficiaries;

•How to ensure benefit-sharing;

•Objective of protection: preservation or commercialization;

•Type, scope, and conditions of protection;

•Nature of rights, acquisition, and enforcement'

•Term of protection: permanent or not; and

•Cultural/customary law dimension.

The Bangui agreement

The
African Intellectual Property Organization (OAPI) was created in 1977
under the Bangui agreement to introduce a uniform law on intellectual
property. The agreement entered into force in 1982 to ensure the
protection of intellectual property rights in most African
French-speaking countries. It acts as a common code of intellectual
property as the principles and provisions of the agreement have the
force of national laws in each OAPI member state. OAPI serves as the
National Office of Industrial Property and the Central Agency for
documentation and information regarding intellectual property in each
member state. The Organization provides intellectual property training
and participates in the development of policies for its member states.73
The Bangui agreement was signed in 1977 and amended in 1999 into the
Agreement of 24 February 1999 Revising the Bangui Agreement of 2 March
1977 on the creation of an African Intellectual Property Organization.
This agreement entered into force on February 28, 2002, and was revised
to comply with the TRIPS agreement. It is divided into 10 annexes that
comprise various intellectual property rights and deals with categories
that have not been dealt with under the 1977 Bangui agreement, such as
protection of plant varieties (Annex X). The protection against unfair
competition has been strengthened and dealt with in Annex VIII,
including acts or practices divulging information without the consent of
the owner or right holder.74,75

The Swakopmund Protocol

A
similar initiative was adopted in 2010, known as the Swakopmund
Protocol on the Protection of Traditional Knowledge and Expressions of
Folklore, which protects the rights of traditional knowledge holders and
prevents misappropriation, misuse, and unlawful exploitation of
expressions of folklore. The Swakopmund protocol was adopted within the
Framework of the African Regional Intellectual Property Organization.76
It is underpinned by the principle that the knowledge, technologies,
biological resources, and cultural heritage of traditional and local
communities are the result of tested practices of past generations and
that these resources are held in trust by current custodians for future
generations.77
The protocol states an explicit intent to address the issue of Prior
Informed Consent, which involves full transparency of information from
the prospective user and acceptance of communities to use their
traditional knowledge or expressions of folklore.

The
legal vacuum of the 1960s and a lack of subsequent implementation of
these international and regional regulations have resulted in continuing
overexploitation of medicinal resources and traditional knowledge
across the African continent, the most notable example being the over
harvesting of P. africana in Cameroon for European markets to treat BPH.

Ethically, access and benefit sharing principles should have been in place before the 1960s exploitation of P. africana
to ensure adequate compensation to traditional knowledge holders for
sharing their knowledge. Legally, access and benefit sharing principles
should have been in place from 1993 when the CBD was adopted
establishing an international standard of equitable benefit sharing.
These international and regional IPR frameworks are still very much in
an evolutionary stage, despite more than two decades of debate and
litigation. This grey area status, particularly with the divergent views
of CBD and TRIPS as to ownership and protection of traditional
knowledge, continues to affect the implementation of access and benefit
sharing principles at national levels.

The management
and protection of IPRs, traditional knowledge, access and benefit
sharing, and plant genetic resources are still limited in many African
countries because of the absence of enforceable national policies, even
though most nations have signed the CBD. African leaders, through the
New Partnership for Africa's Development (NEPAD), have acknowledged and
stressed the importance of protecting and promoting traditional
knowledge and technologies to solve specific problems and improve the
continent's economies. The Southern Africa Network for Biosciences
(SANBio) established under NEPAD has, as a specialized regional
biosciences research and development network, been in the forefront of
promoting the discussion to develop common approaches to intellectual
property rights, technology transfer, and commercialization of
innovations arising therefrom. Recently, SANBio/NEPAD developed new
guidelines on traditional knowledge and plant genetic resources as a
result of growing concerns of inadequate policies and laws in the
Southern African Development Community member states on the use of
traditional knowledge, biological resources, and benefit sharing.78

These
guidelines seek to facilitate the development and implementation of
national policies and legislation for the protection and management of
IPR, traditional knowledge and access and benefit sharing related to the
use of PGR in southern Africa, aiming for sustainable utilization and
management of biological diversity. The guidelines contribute to
building capacity in the region, targeting the development of a national
critical mass of experts through specialized short- and long-term
programs, developing appropriate learning aids, introducing curriculum
on intellectual property at secondary and tertiary levels and
integrating traditional knowledge at national levels of training.78
The SANBio/NEPAD guidelines also present a set of sample contracts. The
application of these guidelines should ensure effective access and
profitable commercialization for the benefit of communities. Until
African countries have appropriate national legislation, the
biodiversity of medicinal resources like P. africana remain at
risk of overexploitation and traditional knowledge holders risk not
receiving just compensation for the knowledge they have shared.

MUTHI Project

In
the spirit of the SANBio/NEPAD emphasis on capacity building via a
national critical mass of experts, MUTHI was established with European
Union funding to build more sustainable plant research capacity and
research networks between key institutions in selected African countries
(Mali, South Africa, and Uganda) and a group of partner European
research institutions to attain enhanced health in Africa.40
Through the MUTHI project's 4-year capacity-building program, African
researchers are trained in the necessary research skills to produce and
commercialize safe and standardized improved traditional medicines. They
are also trained in access and benefit sharing principles.

The MUTHI project commenced in January 2010 and has focused on six broad thematic areas:

1.Medical anthropology and ethnopharmacology.

2.Quality control of phytomedicines and nutraceuticals.

3.Investigative
bioactivity and safety of phytomedicines and nutraceuticals, with the
objectives of assessing the needs of African institutes and developing
capabilities of researchers for: bioassays, data management, quality
assurance, bioactivity evaluation, safety aspects and developing
guidelines.

4.Identify
researchers' needs for clinical and public health training and to build
capacity of improved traditional medicine researchers on all aspects of
the subject, including writing and data analysis.

5.Ethics
and intellectual property rights, aiming to assess training and
education requirements for stakeholders about intellectual property
rights, biodiversity legislation and regulation, access and benefit
sharing, and ethics of traditional medicine and research methods.

6.Project
management. MUTHI represents but one of a range of herbal development
strategies emerging across Africa where science and tradition work
together to generate safe and effective contributions to the promotion
of Africa's health.

The gold
standard referenced by the intellectual property rights work package in
the MUTHI project is the Code of Ethics, which has its origins in the
Declaration of Belém, agreed upon in 1988 at the founding of the
International Society of Ethnobiology, initiated in 1996 and completed
in 2006. The fundamental value underlying the Code of Ethics is
continual willingness to evaluate one's own understandings, actions, and
responsibilities to others, known as the concept of mindfulness. It
acknowledges that biological and cultural harms have resulted from
research undertaken without the consent of Indigenous peoples and
affirms the commitment of the International Society of Ethnobiology to
work collaboratively in ways that support community-driven development
of Indigenous peoples' cultures and languages; acknowledge Indigenous
cultural and intellectual property rights; protect the inextricable
linkages between cultural, linguistic and biological diversity, and
contribute to positive, beneficial, and harmonious relationships in the
field of ethnobiology. The 17 principles of the International Society of
Ethnobiology Code of Ethics that the MUTHI project based its framework
on are outlined in Box 2.79

Box 2. Summary of the 17 Principles of the International Society of Ethnobiology Code of Ethics

1.Prior Rights and Responsibilities

This
acknowledges the prior proprietary rights, interests, and cultural
responsibilities for natural resources that indigenous peoples,
traditional societies, and local communities have, along with the
associated knowledge, intellectual property, and traditional resource
rights.

2.Self-Determination

This
recognizes that indigenous peoples, traditional societies, and local
communities have the right to self-determination, which must be
respected by researchers and associated organizations throughout
interactions.

3.Inalienability

This
refers to the collective and individual inalienable rights of
indigenous peoples, traditional societies, and local communities to
determine the nature, scope, and alienability of the resource rights
regimes on their traditional territories and over their natural
resources.

4.Traditional Guardianship

This
allows for the holistic interconnectedness of people with ecosystems
and the responsibility of indigenous peoples, traditional societies, and
local communities to act as traditional guardians of these ecosystems
by maintaining their cultures, identities, languages, mythologies,
spiritual beliefs, and customary laws and practices.

5.Active Participation

This
recognizes the importance of indigenous peoples, traditional societies,
and local communities to be involved at all research phases and the
application of the results, including collaboration and prior review of
results before dissemination.

6.Full Disclosure

This
covers the entitlement of indigenous peoples, traditional societies,
and local communities to have full understanding of the nature, scope,
and ultimate purpose of the proposed research.

7.Educated Prior Informed Consent

This
occurs before any research is initiated at the collective and
individual level, based on a continuously maintained relationship
throughout the research process, using culturally appropriate tools, and
includes clearly defined risks and benefits to the indigenous peoples,
traditional societies, and local communities affected by the research.

8.Confidentiality

This
ensures that indigenous peoples, traditional societies, and local
communities have the discretion to keep any aspect of their culture,
identity, language, traditions, mythologies, spiritual beliefs, or
genomics confidential and that this confidentiality is guaranteed by
researchers and other potential users.

9.Respect

This
promotes the respect by researchers for the integrity, morality, and
spirituality of the culture, traditions, and relationships of indigenous
peoples, traditional societies, and local communities.

10.Active Protection

This
engages researchers in taking active measures to protect and enhance
relationships of indigenous peoples, traditional societies, and local
communities with their environment and maintain cultural and biological
diversity.

11.Precaution

This
advocates for a proactive, anticipatory approach that aims to mitigate
harm from research activities. The assessment of these potential risks
must incorporate local viewpoints and avoid imposing foreign concepts or
standards.

12.Reciprocity, Mutual Benefit, and Equitable Sharing

This
aims for the mutual benefit and equitable sharing of both tangible and
intangible results from the research with indigenous peoples,
traditional societies, and local communities in a way that is culturally
appropriate.

13.Supporting Indigenous Research

This
supports the efforts of indigenous peoples, traditional societies, and
local communities in pursuing and creating their own research that is
grounded in local customs and epistemology through capacity building,
training, and technology transfers.

14.The Dynamic Interactive Cycle

This
cautions against initiating projects unless there is ample reassurance
that all stages can be completed and seen as cycles of continuous and
ongoing communication and interaction throughout all research phases.

15.Remedial Action

This
implies that, alongside the mitigating actions to prevent harm,
researchers will discuss and decide with indigenous peoples, traditional
societies, and local communities on the remedial actions that will be
taken should any adverse consequences result from the project.

16.Acknowledgment and Due Credit

This
recognizes the importance of acknowledging indigenous peoples,
traditional societies, and local communities in an appropriate way in
all agreed forms of dissemination of results and downstream applications
of resulting knowledge.

17.Diligence

This
calls for the researchers' understanding of the local context before
initiating research relationships, including knowledge of and compliance
with local governance systems, cultural laws and protocols, social
customs and etiquette.

Source: Adapted from the International Society of Ethnobiology Code of Ethics.79

Contrary
to other frameworks, the International Society of Ethnobiology Code of
Ethics addresses the rights of the individual and the community, whereas
existing international and regional legal frameworks focus on the
rights of communities and nation states and do not specifically address
the rights of individual knowledge holders. By integrating this
framework into future research on herbal medicine in Africa, there is
hope for better conservation and harvesting practices in a developing
region that relies heavily on plant based medicine.

Discussion

Sub-Saharan
Africa's 2012–2013 growth rate of 5% positions the region as an
emerging hub of global growth. World Bank data indicate that almost half
of Africa's countries have attained middle-income status.80
Accompanying this is a rising commitment to develop the African
traditional medicine as part of integrated healthcare in Africa,
including the production of a new class of standardized African herbal
medicines.81
As companies and researchers move in this direction, key legal
parameters will need to be observed and enforced. In this context, the
case of P. africana stands as stark testimony to the
consequences of a failure of ethics and enforcement in the development
of Africa's medicinal plants and the traditional knowledge of their use
for human health.

The European Parliament, on of March
11, 2014, adopted new rules on access to genetic resources and the fair
and equitable sharing of benefits resulting from their utilization
(also known as access and benefit sharing) in the European Union. It
also granted consent for the European Union to be legally bound by the
Nagoya Protocol on access and benefit sharing. This means that from the
demand side, European countries will be legally required to ensure
appropriate sharing of benefits arising from the use of genetic
resources, thus contributing to the conservation and sustainable use of
biodiversity.

On the supply side, industry proponents understandably call for a solution that promotes conservation and farming of P. africana,
while keeping rates of production at current or increased levels. A
Norwegian report on the access and benefit sharing aspects of P. africana has argued that the domestication of P. africana is the most obvious way to proceed to develop sustainable production of the bark which also does not endanger wild stocks.44 Indeed, between 1976 and 2007, over 1,610,000 P. africana trees have been planted across montane regions of Cameroon.82 Regeneration of Prunus
stocks is also important, as is preservation of genetic diversity,
which has been found important in ensuring highest quality of actives
needed for BPH management.44

Although
plantation development and efforts towards species regeneration are
constructive, the expanding BPH natural products sub-sector would
benefit from shifting its focus away from this slow growing species
towards a diversity of other medicinal plants that have beneficial
effects on BPH.

For example, Morocco's argan oil from the North African tree Argania spinosa (L.) Skeels (Sapotaceae),83,84 the kernels of the Brazilian native palm tree Attalea speciosa Mart. (Arecaceae) (synonym Orbignya speciosa [Mart.] Barb. Rodr.),85Ganoderma lucidum Fr. Krast (Ganodermataceae),86 and other edible and medicinal mushrooms, Ayurvedic herbal mixtures,87 or Traditional Chinese Medicine (Vaccaria, Plantago Formula, Rehmannia Eight Formula)88,89 and other herbs.90
Despite the popularity of saw palmetto for managing BPH in the United
States and Europe, this plant has been found in an important recent
study to have no beneficial effect on BPH.91

For international consumers, then, P. africana
products are clearly not the only therapeutic option for plant-based
approaches to managing BPH. Preserving Africa's endangered medicinal
trees while cultivating other, more readily renewable African medicinal
plants for common ailments would seem to be a logical shift in industry
focus as Africa moves to develop traditional medicine along scientific,
ethical, and sustainable lines.

68. Mugula BB., de Vries BJ., Bingi SW.
Mechanisms for sustainable use of biodiversity
in and beyond natural ecosystems: a study on conservation and commercial
production of Prunus africana in Uganda. Int J Biodivers Conserv 2010;2:180–185

72. Wu X.
The relationship between the TRIPS agreement and
convention on biological diversity and protection of traditional
knowledge and folklore. WTO-ESCAP-IIUM Regional Workshop on IP
and Public Health and Environment Policy for Asian and Pacific Region;
Online document at www.unescap.org/tid/projects/trips2012-wu2.pdf, accessed September22, 2013